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Quality Assurance Supervisor I

Company Description

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on XFacebookInstagramYouTubeLinkedIn and Tik Tok.

Job Description

The Quality Assurance Supervisor I is responsible for the organization, administration, and supervision of Quality Assurance employees within the manufacturing operations. Responsible for properly overseeing the day-to-day operations by prioritizing shop floor presence and receiving guidance and direction from more senior leaders. This includes delivering high levels of customer service, ensure quality of product and services, comply with all regulatory requirements, achieve desired financial performance including cost reductions, and build a culture of high performance for the team. Ensures that appropriate controls are developed and maintained for new, intermediate and finished products. Responsible for GMP compliance, manufacturing quality, product control and release, system execution and quality planning for the manufacturing areas that it supports.

Responsibilities

  • Responsible for leading a high performing team and prioritizing presence with the team.
  • Leads a team in the Quality function & is responsible for hiring, setting performance expectations, driving team engagement, providing continuous & on-time performance feedback, developing staff, assisting team in problem-solving, & handling of employee matters. Ensures that the department has the appropriate talent & level of performance to meet business objectives. Monitors administration of training identifies training needs, & development of team.
  • Provide Quality support on the manufacturing shop floor
  • Responsible for supporting Operations efforts in meeting established production schedule
  • Partner with Operations employees to document exception documents, including re-inspection and resolve other outstanding plant quality/compliance issues
  • Propose changes update, author, and implement departmental procedures consistent with objectives of simplification and process efficiencies/improvements which ensure ongoing compliance
  • Investigate QC hold, quarantine and reject for materials not meeting standards, ensure the initiation of exception documentation and oversee the implementation of any corrective action
  • Responsible for the review and approval of Procedures and Change Requests
  • Assist/serve/provide feedback on continuous improvement initiatives/teams
  • Reviews and releases batch records.
    May serve as a backup when the Quality Manager is unavailable. Performs other tasks/projects as assigned.

Qualifications

  • Bachelor’s degree in sciences or engineering or equivalent experience
  • 2+ years of experience in a manufacturing production environment.
  • Experience in regulated pharmaceutical industry is preferred.
  • Thorough knowledge of Quality Assurance operations including safety, application of FDA and GMP regulations.
  • Direct manufacturing and regulatory interface experience is preferred.
  • Effective problem-solving, decision-making, teamwork, influence, negotiation, and conflict resolution skills required
  • Ability to work cross-functionally and coordinate work both within the department and with other departments.
  • Ability to identify, communicate, and follow through to completion and assist in the development of necessary corrective action plans to resolve problems with supervision
  • Demonstrated strong leadership skills and ability to foster an inclusive environment

Additional Information

Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: ​​

​​

  • The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future.​​

  • We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.​​

  • This job is eligible to participate in our short-term incentive programs. ​​

​​

Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company’s sole and absolute discretion, consistent with applicable law. ​

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives, serving our community and embracing diversity and inclusion.  It is AbbVie’s policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, status as a protected veteran, or any other legally protected group status.

US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html 

US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:

https://www.abbvie.com/join-us/reasonable-accommodations.html

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Average salary estimate

$75000 / YEARLY (est.)
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$60000K
$90000K

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What You Should Know About Quality Assurance Supervisor I, AbbVie

At AbbVie in North Chicago, IL, we're excited to announce an opening for a Quality Assurance Supervisor I! In this dynamic role, you'll be at the forefront of ensuring that our manufacturing operations maintain the highest standards of quality and compliance while delivering innovative medicines that matter. Your leadership will guide a talented team dedicated to upholding our commitment to excellence across various domains, including immunology and oncology. You will have a hands-on role, actively engaging with your team on the shop floor to prioritize quality service and product integrity while collaborating with cross-functional teams. Additionally, you’ll play a key role in developing and refining operational procedures to promote efficiency and regulatory compliance. Your expertise will empower you to resolve quality issues, oversee batch records, and facilitate training for team members, making a tangible impact on our success. Join us and be a part of a culture that celebrates high performance and fosters inclusion, encouraging everyone to reach their potential. If you're passionate about quality in the pharmaceutical industry and ready to take on a supervisory role, we want to hear from you!

Frequently Asked Questions (FAQs) for Quality Assurance Supervisor I Role at AbbVie
What are the main responsibilities of a Quality Assurance Supervisor I at AbbVie?

A Quality Assurance Supervisor I at AbbVie is responsible for supervising Quality Assurance employees within manufacturing operations. This includes overseeing daily operations, ensuring product quality and compliance with regulatory requirements, mentoring team members, and facilitating effective problem-solving. The position also involves documenting compliance issues and collaborating with other departments to implement corrective actions.

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What qualifications do I need to apply for the Quality Assurance Supervisor I position at AbbVie?

To be considered for the Quality Assurance Supervisor I role at AbbVie, candidates should possess a bachelor’s degree in sciences or engineering, along with at least 2 years of experience in a manufacturing production environment. Experience in the regulated pharmaceutical industry is preferred. A solid understanding of FDA and GMP regulations, as well as effective leadership skills, are also essential for success in this role.

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How does AbbVie ensure compliance with regulatory standards in the Quality Assurance department?

AbbVie ensures compliance in the Quality Assurance department by implementing stringent quality controls and continuously training staff on relevant regulations. The Quality Assurance Supervisor I plays a crucial role by overseeing GMP compliance, managing procedures for quality control, and facilitating investigations into discrepancies, ensuring that all products meet the established quality standards before release.

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What is the work environment like for a Quality Assurance Supervisor I at AbbVie?

The work environment for a Quality Assurance Supervisor I at AbbVie is collaborative and fast-paced, emphasizing team engagement and open communication. Supervisors are expected to maintain a strong presence on the manufacturing shop floor, fostering relationships with team members and collaborating with operations to ensure a smooth production process while upholding quality standards.

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What opportunities for career growth exist for Quality Assurance Supervisor I at AbbVie?

AbbVie offers numerous opportunities for career growth for a Quality Assurance Supervisor I, including mentoring and training programs, leadership development initiatives, and the possibility to advance to more senior quality assurance roles. The company values employee development and continuously looks for ways to support staff in achieving their career aspirations.

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Common Interview Questions for Quality Assurance Supervisor I
Can you describe your experience with quality assurance in a manufacturing setting?

When answering this question, highlight specific examples from your past roles where you successfully ensured product quality and compliance. Mention any experience you have with regulatory requirements and how you fostered a quality culture within your team.

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What strategies do you use to engage and motivate your team?

Discuss your approach to teamwork, highlighting methods like mentoring, setting clear performance expectations, and facilitating open communication. Showcase examples where your leadership led to improved team performance or resolution of conflicts.

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How do you handle non-compliance or quality issues found during manufacturing?

Emphasize your systematic approach to problem-solving, including your process for identifying, documenting, and addressing quality issues. Discuss how you collaborate with other departments to implement corrective actions and prevent recurrence.

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What is your experience with training and developing staff in a quality assurance role?

Share examples of how you've identified training needs within your team, created training sessions, and monitored progress. Highlight any initiatives you've implemented that resulted in improved team capabilities and compliance.

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Describe a time you had to implement a new procedure. What was your approach?

Outline how you assessed the need for the new procedure, involved relevant stakeholders, and communicated changes effectively. Discuss the implementation process and how you ensured that team members understood and followed the new procedure.

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How do you stay up-to-date with changes in regulations and quality assurance best practices?

Mention specific resources you leverage, such as industry publications, professional organizations, or continued education programs. Share how you apply this knowledge in your role and encourage your team's ongoing learning.

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What tools or methods do you use to monitor quality metrics?

Discuss any software or systems you have experience with to track quality metrics, as well as how you analyze data to identify trends and areas for improvement. Demonstrate your familiarity with reporting tools and continuous improvement methodologies.

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Can you provide an example of a successful project you led in quality assurance?

Detail a specific project where your leadership resulted in measurable improvements in quality or compliance. Highlight your role, the actions you took, and the outcomes, emphasizing how the project benefited the organization.

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How do you approach cross-functional collaboration to address quality issues?

Showcase your ability to work with various departments to resolve quality concerns. Provide examples of how you've facilitated meetings, combined efforts, or communicated effectively to address and solve problems collectively.

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What do you think is the most important quality for a Quality Assurance Supervisor I?

Reflect on the essential qualities such as leadership, attention to detail, and communication skills. Tie these back to AbbVie's mission and values to show alignment with the company's goals and culture.

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AbbVie’s mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people’s lives across several key therapeutic areas: i...

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